DepressionMUDGAMENCT06536530
Benefits of Exergames on Neurocognitive Functions in Adults Suffering From Depression
A study testing Exergame-Based Training, Cognitive-Based Training and Wait-List in people with Depression, run by MAP Institute.
Trial summary
The purpose of this study is to analyse the changes derived from exergames (videogames that include cognitive and physical stimulation simultaneously), in terms of cognitive functioning, psychomotor abilities, and its neural substrate, in adults suffering from depression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Exergame-Based Training, Cognitive-Based Training and Wait-List
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Using the Beck Depression Inventory-Second Edition (BDI-II), a scored considered for inclusion criteria where depression (≥ 28 points on BDI-II), confirmed by psychological interview.
- A sufficient level of education to understand study procedures and be able to communicate with site personnel
Who cannot join
- Participants suffering from depression with comorbidities (bipolar disorder, obsessive-compulsion disorder, neurological disorder, or traumatic brain injury) will be excluded.
- <20/60 vision with or without correction
- Inability to complete the activities
- Communication problems
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: MUDgame A Randomized Multi-Arm Controlled Experiment for Measuring the Benefits of an Exergame-based Intervention on Neuro-cognitive Functions in Adults Suffering From Depression
The purpose of this study is to analyse the changes derived from exergames (videogames that include cognitive and physical stimulation simultaneously), in terms of cognitive functioning, psychomotor abilities, and its neural substrate, in adults suffering from depression.
Read the detailed description
The experiment will consist in a randomized three-arms controlled study. After being informed about the study and potential risks, and given written informed consent, adult participants with depression will be randomly distributed into three experimental groups: an intervention group that will train with exergames, an active control group that will train only with cognitive games, and a passive control group or wait-list.
Cognitive Functions will be evaluated in three different moments: before the training intervention, after the intervention, and three months after finishing the training intervention.
Researchers will collect cognitive-behavioral and neural information (event-related potentials), and performing analysis of variance to compare the outcomes of the diverse groups at the three different time points, scientists will analyse the benefits of exergames on cognition.
- Conditions
- Depression
- Being tested
- Exergame-Based Training, Cognitive-Based Training, Wait-List
- Keywords
- cognition, neuropsychology, neuroplasticity, event related potentials, exergames, video games
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exergame-Based TrainingBehavioural
40-50 min sessions, two sessions per week, for a total of eight weeks.
Cognitive-Based TrainingBehavioural
40-50 min sessions, two sessions per week, for a total of eight weeks.
Wait-ListBehavioural
Participants will not train with any program and they will not assist to any specific session or intervention
| Study group | Role | What they receive |
|---|---|---|
| Exergame-Based Training | Experimental | Participants train with exergames (video games that include cognitive and physical training simultaneously), The training regime consists of 40-50 min sessions, two sessions per week, for a total of eight weeks of individual training. Receives: Behavioral: Exergame-Based Training |
| Cognitive-Based Training | Active comparator | Participants will train only with cognitive video games. The training regime consists of 40-50 min sessions, two sessions per week, for a total of eight weeks of individual training. Receives: Behavioral: Cognitive-Based Training |
| Wait-List | Placebo comparator | Participants will not train with any program and they will not assist to any specific session. Receives: Behavioral: Wait-List |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Neuropsychological and Cognitive Functions (Executive Functions measured with the Wisconsin Card Sorting Test) after eight weeks of training intervention or placebo condition.
Researchers will use valid and realiable experimental tasks to measure the psychological functions after eight weeks of training. Executive functions (Wisconsin Card Sorting Test). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials).
(This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Measured: Baseline and after eight weeks of training (Pre-assessment and Post-assessment)
Change from Baseline in Neuropsychological and Cognitive Functions (Memory will be measured with the tests Digit Spam Forward and Digit Spam Backward, from the Wechsler Memory Scale) after eight weeks of training intervention or placebo condition.
Researchers will use valid and realiable experimental tasks to measure the psychological functions after eight weeks of training. Memory (measured with the tests Digit Spam Forward and Digit Spam Backward, from the Wechsler Memory Scale). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials).
(This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Measured: Baseline and after eight weeks of training (Pre-assessment and Post-assessment)
Change from Baseline in Neuropsychological and Cognitive Functions (Attention; sustained attention will be measured with the Sustained Attention to Response Task, SART) after eight weeks of training intervention or placebo condition.
Researchers will use valid and realiable experimental tasks to measure the psychological functions after eight weeks of training. Attention (measured with the Sustained Attention to Response Task). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials).
(This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Measured: Baseline and after eight weeks of training (Pre-assessment and Post-assessment)
Change from Baseline in Neuropsychological and Cognitive Functions (Perception, visual perception will be measured with a classical Visual Search Task) after eight weeks of training intervention or placebo condition.
Researchers will use valid and realiable experimental tasks to measure the psychological functions after eight weeks of training. Perception (measured with a classical Visual Search Task). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials).
(This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Measured: Baseline and after eight weeks of training (Pre-assessment and Post-assessment)
Change from Baseline in Neuropsychological and Cognitive Functions (Processing Speed, measured with a Simple Reaction Times Task) after eight weeks of training intervention or placebo condition.
Researchers will use valid and realiable experimental tasks to measure the psychological functions after eight weeks of training. Processing Speed (measured with a Simple Reaction Times Task). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials).
(This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Measured: Baseline and after eight weeks of training (Pre-assessment and Post-assessment)
Change from Baseline in Neuropsychological and Cognitive Functions (Psychomotor functions, measured with the Salpêtrière Retardation Rating Scale) after eight weeks of training intervention or placebo condition.
Researchers will use valid and realiable experimental tasks to measure the psychological functions after eight weeks of training. Psychomotor functions (measured with the Salpetriere Retardation Rating Scale). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials).
(This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Measured: Baseline and after eight weeks of training (Pre-assessment and Post-assessment)
Change from Post-assessment in Neuropsychological and Cognitive Functions (Executive functions measured with Wisconsin Card Sorting Test) after 3-month follow-up.
Researchers will use valid and realiable experimental tasks to measure the psychological functions after 3-month follow-up. Executive functions (measured with Wisconsin Card Sorting Test). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials).
(This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Measured: Three-month follow-up
Change from Post-assessment in Neuropsychological and Cognitive Functions (Memory will be measured with the tests Digit Spam Forward and Digit Spam Backward, from the Wechsler Memory Scale) after 3-month follow-up.
Researchers will use valid and realiable experimental tasks to measure the psychological functions after 3-month follow-up. Memory (measured with the tests Digit Spam Forward and Digit Spam Backward, from the Wechsler Memory Scale). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials).
(This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Measured: Three-month follow-up
Change from Post-assessment in Neuropsychological and Cognitive Functions (Attention; sustained attention will be measured with the Sustained Attention to Response Task) after 3-month follow-up.
Researchers will use valid and realiable experimental tasks to measure the psychological functions after 3-month follow-up. Attention (measured with the Sustained Attention to Response Task). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials).
(This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Measured: Three-month follow-up
Change from Post-assessment in Neuropsychological and Cognitive Functions (Perception, visual perception will be measured with a classical Visual Search Task) after 3-month follow-up.
Researchers will use valid and realiable experimental tasks to measure the psychological functions after 3-month follow-up. Perception (measured with a classical Visual Search Task). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials).
(This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Measured: Three-month follow-up
Change from Post-assessment in Neuropsychological and Cognitive Functions (Processing Speed, measured with a Simple Reaction Times Task) after 3-month follow-up.
Researchers will use valid and realiable experimental tasks to measure the psychological functions after 3-month follow-up. Processing Speed (measured with a Simple Reaction Times Task). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials).
(This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Measured: Three-month follow-up
Change from Post-assessment in Neuropsychological and Cognitive Functions (Psychomotor functions, measured with the Salpêtrière Retardation Rating Scale) after 3-month follow-up.
Researchers will use valid and realiable experimental tasks to measure the psychological functions after 3-month follow-up. Psychomotor functions (measured with the Salpetriere Retardation Rating Scale). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials).
(This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Measured: Three-month follow-up
Secondary outcomes (6)
Change from Baseline in Placebo Effect measures (Motivation) after eight weeks of training.
To measure the changes form baseline to the post-intervention, researchers will use to measure motivation a self-report 5-point Likert-type scale (1 = not motivated, to 5 = extremely motivated)
(This test is going to be used as a experimental self-report and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value regarding the results).
Measured: Baseline and after eight weeks of training (Pre-assessment, Post-assessment)
Change from Baseline in Placebo Effect measures (Engagement) after eight weeks of training.
To measure the changes form baseline to the post-intervention, researchers will use to measure engagement a self-report 5-point Likert-type scale (1 = not engaged, to 5 = extremely immersed).
(This test is going to be used as a experimental self-report and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value regarding the results).
Measured: Baseline and after eight weeks of training (Pre-assessment, Post-assessment)
Change from Baseline in Placebo Effect measures (Expectations) after eight weeks of training.
To measure the changes form baseline to the post-intervention, researchers will use to measure expectations, a self-report 5-point Likert-type (1 = the results will be much worse, 3 = there will not be any change, 5 = the results will be much better).
(This test is going to be used as a experimental self-report and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value regarding the results).
Measured: Baseline and after eight weeks of training (Pre-assessment, Post-assessment)
Change from post-assessment in Placebo Effect measures (Motivation) after 3-month follow-up.
To measure the changes form post-test to the 3-month follow-up, researchers will use to measure motivation a self-report 5-point Likert-type scale (1 = not motivated, to 5 = extremely motivated)
(This test is going to be used as a experimental self-report and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value regarding the results).
Measured: Three-month follow-up
Change from post-assessment in Placebo Effect measures (Engagement) after 3-month follow-up.
To measure the changes form post-test to the 3-month follow-up, researchers will use to measure engagement a self-report 5-point Likert-type scale (1 = not engaged, to 5 = extremely immersed).
(This test is going to be used as a experimental self-report and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value regarding the results).
Measured: Three-month follow-up
Change from post-assessment in Placebo Effect measures (Expectations) after 3-month follow-up.
To measure the changes form post-test to the 3-month follow-up, researchers will use to measure expectations, a self-report 5-point Likert-type (1 = the results will be much worse, 3 = there will not be any change, 5 = the results will be much better).
(This test is going to be used as a experimental self-report and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value regarding the results).
Measured: Three-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study startJan 2027 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This project consists in a three-arms parallel-group randomized study to measure the benefits of exergames on cognition, in adults suffering from depression. Researchers will compare three different interventions (training with an exergame, which combines cognitive and physical stimulation, training with a cognitive game, and a wait-list condition), by randomizing participants to each group with equal probability.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MAP Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PhD Prof. Eloisa Ruiz-Marquez, MAP Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536530
- Sponsor's protocol ID
- z4s9q
- Acronym
- MUDGAME
- Status last verified
- Jul 2025
- First submitted
- 23 Jul 2024
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The available data will be individual participant data that underlie the results reported in the articles, after deidentification (text, tables, figures, and appendices), Study Protocol, Statistical Analysis Plan and Informed Consent Form.
Publications
Ruiz-Marquez E. Neurophysiology of executive cognitive functions under depression. Explor Neurosci. 2025;4:100696. https://doi.org/10.37349/en.2025.100696
Ruiz-Marquez E. Protocol for measuring the benefits of exergames on executive functions under depression through a randomized multi-arm controlled experiment. Explor Neurosci. 2024;3:564-83. https://doi.org/10.37349/en. 2024.00068
Ruiz-Marquez, E. (2023). Protocol for measuring the benefits of exergames on executive functions under depression through a randomized multi-arm controlled experiment. Preprint. Open Science Framework.https://doi.org/10.31234/osf.io/m7s2t_v1
Ruiz-Marquez, E. (2025). Neurophysiology of executive cognitive functions under depression. Preprint. Open Science Framework. https://doi.org/10.37349/en.2025.100696
Ruiz-Marquez, E.,(2024). MUDgame. Measuring the Benefits of an Exergame-based intervention on Neuro-Cognitive Functions in adults suffering from Depression. A Randomized Multi-Arm Controlled Experiment. Project. Open Science Framework. https://doi.org/10.17605/OSF.IO/YBDCT
Ruiz-Marquez, E. (2023). MUDgame. Measuring the Benefits of an Exergame-based intervention on Neuro-Cognitive Functions in adults suffering from Depression. A Randomized Multi-Arm Controlled Experiment. Preregistration. Open Science Framework. https://doi.org/10.17605/OSF.IO/Z4S9Q
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MUDgame A Randomized Multi-Arm Controlled Experiment for Measuring the Benefits of an Exergame-based Intervention on Neuro-cognitive Functions in Adults Suffering From Depression
- ClinicalTrials.gov ID
- NCT06536530
- Acronym / sponsor ID
- MUDGAME / z4s9q
- Conditions
- Depression
- Keywords
- cognition, neuropsychology, neuroplasticity, event related potentials, exergames, video games
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- MAP InstituteUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to analyse the changes derived from exergames (videogames that include cognitive and physical stimulation simultaneously), in terms of cognitive functioning, psychomotor abilities, and its neural substrate, in adults suffering from depression.
Detailed description
The experiment will consist in a randomized three-arms controlled study. After being informed about the study and potential risks, and given written informed consent, adult participants with depression will be randomly distributed into three experimental groups: an intervention group that will train with exergames, an active control group that will train only with cognitive games, and a passive control group or wait-list.
Cognitive Functions will be evaluated in three different moments: before the training intervention, after the intervention, and three months after finishing the training intervention.
Researchers will collect cognitive-behavioral and neural information (event-related potentials), and performing analysis of variance to compare the outcomes of the diverse groups at the three different time points, scientists will analyse the benefits of exergames on cognition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This project consists in a three-arms parallel-group randomized study to measure the benefits of exergames on cognition, in adults suffering from depression. Researchers will compare three different interventions (training with an exergame, which combines cognitive and physical stimulation, training with a cognitive game, and a wait-list condition), by randomizing participants to each group with equal probability.
| Arm | Type | Receives |
|---|---|---|
| Exergame-Based Training | Experimental | Behavioral: Exergame-Based TrainingParticipants train with exergames (video games that include cognitive and physical training simultaneously), The training regime consists of 40-50 min sessions, two sessions per week, for a total of eight weeks of individual training. |
| Cognitive-Based Training | Active comparator | Behavioral: Cognitive-Based TrainingParticipants will train only with cognitive video games. The training regime consists of 40-50 min sessions, two sessions per week, for a total of eight weeks of individual training. |
| Wait-List | Placebo comparator | Behavioral: Wait-ListParticipants will not train with any program and they will not assist to any specific session. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Using the Beck Depression Inventory-Second Edition (BDI-II), a scored considered for inclusion criteria where depression (≥ 28 points on BDI-II), confirmed by psychological interview.
- A sufficient level of education to understand study procedures and be able to communicate with site personnel
Key exclusion criteria (4 listed)
- Participants suffering from depression with comorbidities (bipolar disorder, obsessive-compulsion disorder, neurological disorder, or traumatic brain injury) will be excluded.
- <20/60 vision with or without correction
- Inability to complete the activities
- Communication problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exergame-Based Training40-50 min sessions, two sessions per week, for a total of eight weeks. | Behavioural | Exergame-Based Training |
| Cognitive-Based Training40-50 min sessions, two sessions per week, for a total of eight weeks. | Behavioural | Cognitive-Based Training |
| Wait-ListParticipants will not train with any program and they will not assist to any specific session or intervention | Behavioural | Wait-List |
Primary outcome
Change from Baseline in Neuropsychological and Cognitive Functions (Executive Functions measured with the Wisconsin Card Sorting Test) after eight weeks of training intervention or placebo condition.
Time frame: Baseline and after eight weeks of training (Pre-assessment and Post-assessment)
Researchers will use valid and realiable experimental tasks to measure the psychological functions after eight weeks of training. Executive functions (Wisconsin Card Sorting Test). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials). (This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Change from Baseline in Neuropsychological and Cognitive Functions (Memory will be measured with the tests Digit Spam Forward and Digit Spam Backward, from the Wechsler Memory Scale) after eight weeks of training intervention or placebo condition.
Time frame: Baseline and after eight weeks of training (Pre-assessment and Post-assessment)
Researchers will use valid and realiable experimental tasks to measure the psychological functions after eight weeks of training. Memory (measured with the tests Digit Spam Forward and Digit Spam Backward, from the Wechsler Memory Scale). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials). (This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Change from Baseline in Neuropsychological and Cognitive Functions (Attention; sustained attention will be measured with the Sustained Attention to Response Task, SART) after eight weeks of training intervention or placebo condition.
Time frame: Baseline and after eight weeks of training (Pre-assessment and Post-assessment)
Researchers will use valid and realiable experimental tasks to measure the psychological functions after eight weeks of training. Attention (measured with the Sustained Attention to Response Task). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials). (This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Change from Baseline in Neuropsychological and Cognitive Functions (Perception, visual perception will be measured with a classical Visual Search Task) after eight weeks of training intervention or placebo condition.
Time frame: Baseline and after eight weeks of training (Pre-assessment and Post-assessment)
Researchers will use valid and realiable experimental tasks to measure the psychological functions after eight weeks of training. Perception (measured with a classical Visual Search Task). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials). (This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Change from Baseline in Neuropsychological and Cognitive Functions (Processing Speed, measured with a Simple Reaction Times Task) after eight weeks of training intervention or placebo condition.
Time frame: Baseline and after eight weeks of training (Pre-assessment and Post-assessment)
Researchers will use valid and realiable experimental tasks to measure the psychological functions after eight weeks of training. Processing Speed (measured with a Simple Reaction Times Task). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials). (This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Change from Baseline in Neuropsychological and Cognitive Functions (Psychomotor functions, measured with the Salpêtrière Retardation Rating Scale) after eight weeks of training intervention or placebo condition.
Time frame: Baseline and after eight weeks of training (Pre-assessment and Post-assessment)
Researchers will use valid and realiable experimental tasks to measure the psychological functions after eight weeks of training. Psychomotor functions (measured with the Salpetriere Retardation Rating Scale). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials). (This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Change from Post-assessment in Neuropsychological and Cognitive Functions (Executive functions measured with Wisconsin Card Sorting Test) after 3-month follow-up.
Time frame: Three-month follow-up
Researchers will use valid and realiable experimental tasks to measure the psychological functions after 3-month follow-up. Executive functions (measured with Wisconsin Card Sorting Test). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials). (This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Change from Post-assessment in Neuropsychological and Cognitive Functions (Memory will be measured with the tests Digit Spam Forward and Digit Spam Backward, from the Wechsler Memory Scale) after 3-month follow-up.
Time frame: Three-month follow-up
Researchers will use valid and realiable experimental tasks to measure the psychological functions after 3-month follow-up. Memory (measured with the tests Digit Spam Forward and Digit Spam Backward, from the Wechsler Memory Scale). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials). (This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Change from Post-assessment in Neuropsychological and Cognitive Functions (Attention; sustained attention will be measured with the Sustained Attention to Response Task) after 3-month follow-up.
Time frame: Three-month follow-up
Researchers will use valid and realiable experimental tasks to measure the psychological functions after 3-month follow-up. Attention (measured with the Sustained Attention to Response Task). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials). (This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Change from Post-assessment in Neuropsychological and Cognitive Functions (Perception, visual perception will be measured with a classical Visual Search Task) after 3-month follow-up.
Time frame: Three-month follow-up
Researchers will use valid and realiable experimental tasks to measure the psychological functions after 3-month follow-up. Perception (measured with a classical Visual Search Task). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials). (This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Change from Post-assessment in Neuropsychological and Cognitive Functions (Processing Speed, measured with a Simple Reaction Times Task) after 3-month follow-up.
Time frame: Three-month follow-up
Researchers will use valid and realiable experimental tasks to measure the psychological functions after 3-month follow-up. Processing Speed (measured with a Simple Reaction Times Task). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials). (This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Change from Post-assessment in Neuropsychological and Cognitive Functions (Psychomotor functions, measured with the Salpêtrière Retardation Rating Scale) after 3-month follow-up.
Time frame: Three-month follow-up
Researchers will use valid and realiable experimental tasks to measure the psychological functions after 3-month follow-up. Psychomotor functions (measured with the Salpetriere Retardation Rating Scale). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials). (This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
6 secondary outcomes
Change from Baseline in Placebo Effect measures (Motivation) after eight weeks of training.
Time frame: Baseline and after eight weeks of training (Pre-assessment, Post-assessment)
Change from Baseline in Placebo Effect measures (Engagement) after eight weeks of training.
Time frame: Baseline and after eight weeks of training (Pre-assessment, Post-assessment)
Change from Baseline in Placebo Effect measures (Expectations) after eight weeks of training.
Time frame: Baseline and after eight weeks of training (Pre-assessment, Post-assessment)
Change from post-assessment in Placebo Effect measures (Motivation) after 3-month follow-up.
Time frame: Three-month follow-up
Change from post-assessment in Placebo Effect measures (Engagement) after 3-month follow-up.
Time frame: Three-month follow-up
Change from post-assessment in Placebo Effect measures (Expectations) after 3-month follow-up.
Time frame: Three-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- BackgroundRuiz-Marquez E. Neurophysiology of executive cognitive functions under depression. Explor Neurosci. 2025;4:100696. https://doi.org/10.37349/en.2025.100696
- BackgroundRuiz-Marquez E. Protocol for measuring the benefits of exergames on executive functions under depression through a randomized multi-arm controlled experiment. Explor Neurosci. 2024;3:564-83. https://doi.org/10.37349/en. 2024.00068
- BackgroundRuiz-Marquez, E. (2023). Protocol for measuring the benefits of exergames on executive functions under depression through a randomized multi-arm controlled experiment. Preprint. Open Science Framework.https://doi.org/10.31234/osf.io/m7s2t_v1
- BackgroundRuiz-Marquez, E. (2025). Neurophysiology of executive cognitive functions under depression. Preprint. Open Science Framework. https://doi.org/10.37349/en.2025.100696
- BackgroundRuiz-Marquez, E.,(2024). MUDgame. Measuring the Benefits of an Exergame-based intervention on Neuro-Cognitive Functions in adults suffering from Depression. A Randomized Multi-Arm Controlled Experiment. Project. Open Science Framework. https://doi.org/10.17605/OSF.IO/YBDCT
- BackgroundRuiz-Marquez, E. (2023). MUDgame. Measuring the Benefits of an Exergame-based intervention on Neuro-Cognitive Functions in adults suffering from Depression. A Randomized Multi-Arm Controlled Experiment. Preregistration. Open Science Framework. https://doi.org/10.17605/OSF.IO/Z4S9Q
- Individual participant dataSharing planned: Yes. The available data will be individual participant data that underlie the results reported in the articles, after deidentification (text, tables, figures, and appendices), Study Protocol, Statistical Analysis Plan and Informed Consent Form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Exergame-Based Training, Cognitive-Based Training and Wait-List in people with Depression, run by MAP Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eloisa Ruiz-Marquez (643862849 ext. 0034, sci@mapesinstitute.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Neuropsychological and Cognitive Functions (Executive Functions measured with the Wisconsin Card Sorting Test) after eight weeks of training intervention or placebo condition. (time frame: Baseline and after eight weeks of training (Pre-assessment and Post-assessment)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06536530, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.